FDA 510(k)

MR5 Activ Pro

Número K: K254024 · 2026-05-19

Data da decisão2026-05-19

Código do produtoNHN

Comité consultivoPM

DecisãoSubstantially Equivalent

Resumo do dispositivo

MR5 Activ Pro is the device name listed in this FDA 510(k) record. The listed applicant is Multi Radiance Medical, Inc.. It received FDA 510(k) clearance on 2026-05-19 under 510(k) number K254024. The device is classified under product code NHN. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the MR5 Activ Pro?

MR5 Activ Pro is a medical device that received FDA 510(k) clearance on 2026-05-19. The listed applicant is Multi Radiance Medical, Inc.. The 510(k) number is K254024.

When did MR5 Activ Pro receive FDA 510(k) clearance?

MR5 Activ Pro received FDA 510(k) clearance on 2026-05-19, under 510(k) number K254024.

Who is the listed applicant for MR5 Activ Pro?

The FDA 510(k) record lists Multi Radiance Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MR5 Activ Pro?

The FDA product code for MR5 Activ Pro is NHN.

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Fonte oficial

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